QA Validation Engineer

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development empowering our team members to grow personally and professionally.

Position Overview

The QA Validation ensures that all commissioning and qualification activities under the project scope is designed in compliance with all applicable site Quality policies, regulatory requirement, and GMP practices/ procedures in place and in use within the site.

Key Responsibilities

• Drive quality-by-design across all project stages in line with the Project Quality System and Plan.
• Ensure compliance with regulatory requirements, the Quality Management System (QMS), and local procedures throughout the project lifecycle.
• Identify and mitigate potential quality risks early to minimize disruptions and maintain GMP compliance.
• Execute quality gap assessments and ensure effective integration between new and existing GMP operations.
• Oversee commissioning and validation activities, ensuring alignment with project plans and schedules.
• Review and approve commissioning, qualification, risk assessments, and key engineering documents.
• Ensure operational procedures support validated processes and GMP standards.

Required Qualifications

• Minimum 3 years experience as Quality Assurance and/or Validation engineer
• Experience in pharmaceutical industry in GMP regulated areas
• Understanding of cGMP and regulatory requirement (i.e. EU Annex 01, ICH Q7, 8 and 9) within Pharmaceutical industry
• Strong knowledge of commissioning and qualification requirement of fixed and mobile equipment, systems and single use system (preferred)
• Good knowledge of computerized system validation of equipment or connected process control systems (preferred)
• Good knowledge of cross contamination control and sterile processing
• Hands-on experience in Pharmaceutical manufacturing (preferred)
• Developing Project management skills or had hands-on experience in Project management (preferred)
• Ability to apply optimal quality assurance standards to support project team for timely progress of the project milestones
• Ability to facilitate project deliverables compatible to international regulatory environment
• Ability to communicate to and influence stakeholders effectively
• Ability to apply risk management skills adequately

Why join us?

• Generous Leave Policy 
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.